GMP Regulatory Compliance Specialist

Job OverviewFUJIFILM Diosynth Biotechnologies is seeking a highly skilled Regulatory Compliance Specialist to join our Supply Chain team in Hillerod. As a key member of our team, you will play a vital role in ensuring compliance with GMP regulations and maintaining the highest standards of quality.

We are seeking a detail-oriented Regulatory Compliance Specialist to join our team in Hillerød, Denmark.FUJIFILM Diosynth Biotechnologies (FDB) is a leading Contract Development and Manufacturing Organization (CDMO) with sites worldwide. In our Hillerød location, we have approximately 1700 employees working on every aspect of biotech and pharmaceutical...

Fujifilm Diosynth Biotechnologies is a leading biotech company that develops and manufactures innovative biological products. We are seeking a Quality Assurance Specialist to join our team in Hillerød, Denmark.About the RoleThe successful candidate will be responsible for ensuring GxP compliance through change controls, quality agreement revisions, and...

Job OverviewThis is an exciting opportunity to join Novo Nordisk A/S as a Senior GMP Expert, playing a pivotal role in ensuring the highest level of quality and compliance within Product Control and Global Support.About the RoleThe successful candidate will be responsible for managing various quality-related activities across the department, guiding team...

We are seeking an experienced Facility Subject Matter Expert to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our Facility Group, you will provide expert guidance on GMP-related matters and ensure the smooth operation of our facility.Job DescriptionThe ideal candidate will have extensive knowledge of cGMP regulations and guidelines,...

About the JobWe are seeking a skilled Chromatographic Specialist to join our team in Hillerød, Denmark. As a key member of our Analytical Development department, you will be responsible for validating and verifying chromatographic methods, leading projects, and providing QC support.The Ideal CandidateHas a Master's Degree in Chemistry, Pharmacy,...

Novo Nordisk A/S is a life-science company dedicated to ensuring that people can lead a life independent of chronic disease. Our Assembly in Hillerød department focuses on increasing production capacity while maintaining high quality standards and employee well-being.We are seeking a Quality Assurance Specialist to support both management and colleagues on...

About the RoleWe are seeking a Chief IT Compliance Officer to lead our global IT compliance team. The successful candidate will develop and implement effective compliance strategies, ensuring alignment with regulatory requirements.

Job DescriptionWe are seeking a highly skilled Site Management Specialist to join our team at Fujifilm Diosynth Biotechnologies. As a key member of our Facility Group, you will be responsible for driving and implementing changes related to minor projects on our Hillerod site.About the RoleIn this role, you will work closely with internal and external...

Fujifilm Diosynth Biotechnologies seeks a highly skilled Senior Quality Manager for its manufacturing operations. This role is responsible for ensuring the highest quality standards are met in all aspects of production, from initial development to final product delivery.Job OverviewThe successful candidate will lead the Program Quality Management team,...

About the RoleThis is an exciting opportunity to join the Global Quality team at Fujifilm Diosynth Biotechnologies as a Stability Specialist. In this role, you will be responsible for managing stability studies and supporting procedures and projects.Key Responsibilities:Author and maintain stability protocols and specificationsCreate Change Controls within...

About the RoleWe are seeking a highly skilled Innovative Usability Specialist to join our team at Novo Nordisk A/S. As a key member of our Devices and Delivery Solutions department, you will play a vital role in shaping the user experience of our medical devices and digital health products.Job DescriptionYour primary responsibility will be to plan,...

About the RoleWe are seeking a highly skilled Digital QA Expert to join our team in Hillerød, Denmark.Job DescriptionThe successful candidate will be responsible for ensuring the quality and compliance of all processes in FPMSAT, including product development and life cycle management, design control, testing, manufacturing development, and manufacturing...

About the RoleWe are seeking a highly skilled Chromatographic Senior Chemist to join our analytical development team at Novo Nordisk A/S. The ideal candidate will have a strong background in chromatographic methods, pharmacopoeia compliance, and regulatory requirements.Key ResponsibilitiesDevelop and validate chromatographic methods for complex materials,...

We are seeking a highly skilled Senior Quality Manager to join our team in Novo Nordisk A/S. As a Senior Quality Manager, you will be responsible for maintaining a high level of compliance with cGMP and Novo Nordisk's Quality Management System.Job DescriptionThe role involves supporting the department in developing and maintaining a high cGMP level. Key...

About the RoleAs an IT System Management Specialist at Novo Nordisk A/S, you will play a pivotal role in scaling up our computerized equipment landscape within a rapidly growing organization. This challenging opportunity involves driving IT system management for critical local IT systems and ensuring compliance with regulatory requirements.Key...

About the RoleAs a seasoned quality assurance professional, you will play a critical role in ensuring our vendors and suppliers adhere to relevant legislation (GxP, medical devices, etc.) through onsite and virtual audits, assessments, and questionnaires. This position requires a sound judgment and risk-based approach to identify areas of improvement and...

As a Senior Raw Materials Sampling Specialist for our Quality Control team at Fujifilm Diosynth Biotechnologies, you will play a vital role in ensuring the readiness of all raw materials for production. Our dynamic QC Raw Materials Department is responsible for sampling and testing raw materials at our manufacturing site in Hillerød.You will be working in...

Job DescriptionThe Facility Professional role is a key position within the Facility Group, which comprises 15 highly skilled individuals.You will be working in close collaboration with the Facility Project SME on large CAPEX projects, driving and implementing GMP- and NON GMP changes related to minor projects on the Hillerod Site.This involves being an...

About the RoleWe are seeking an experienced API Production Engineer to join our team at Novo Nordisk A/S, where you will play a pivotal role in ensuring the quality and compliance of our API production facility. In this position, you will be responsible for leading cross-functional teams to implement standardized quality-related tools, monitor quality during...